24 - Week Flibanserin 100mg for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women in Noth America
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Sprout Pharmaceuticals, Inc
- Enrollment
- 748
- Locations
- 100
- Primary Endpoint
- Change From Baseline in the Number of Satisfying Sexual Events
Study Overview
Brief Summary
The objective of this trial is to assess the safety and efficacy of 24-week course of flibanserin for the treatment of Hypoactive Sexual Desire Disorder (HSDD) in naturally postmenopausal women.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 35 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Flibanserin 100 mg
Flibanserin 100 mg administered at bedtime
Intervention: Flibanserin (Drug)
Placebo
This is the matched placebo which will be administered two tablets daily at bedtime.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change From Baseline in the Number of Satisfying Sexual Events
Time Frame: baseline to 24 weeks
The change from baseline in the number of SSE's as measured by the eDiary. The calculation of Satisfying Sexual Event (SSEs) will be standardized to a 28-day period according to the below formula: Total monthly events = 28 x (sum of the number of events) / (sum of number of days entered). "Satisfying" means gratifying, fulfilling, satisfactory, and/or successful for the patient. The partner's satisfaction is not the subject of this question.
Change From Baseline in the Score on the Female Sexual Function Index (FSFI) Desire Domain
Time Frame: baseline to 24 weeks
The Female Sexual Function Index (FSFI) is a brief, multidimensional, self-administered questionnaire for assessing key domains of sexual function in women. The scale consists of 19 items that assess sexual function over the past four weeks and yields scores in six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The two items in the desire domain are scored from 1 to 5 (1 is lowest level of desire and 5 is the highest level of desire). The raw scores of the two items are added together and then multiplied by the domain factor of 0.6. Thus, the score of the desire domain ranges from 1.2 (lowest level of desire) to 6.0 (highest level of desire). For the entire instrument, each of the six domains contributes a maximum of 6 points to the total. Scores on the full scale range from a minimum of 2 to a maximum of 36.
Secondary Outcomes
No secondary outcomes reported